It is well known that there are literally millions of patients throughout the world who suffer pain in various parts of their bodies. Three of the most frequent sites for pain are: (1) foot pain caused by chemotherapy or diabetic neuropathy; (2) shoulder pain often resulting from a tear or inflammation of the rotator cuff; and (3) lower back pain caused by a large variety of medical problems, particularly associated with the spine and the nerves surrounding the vertebrae. Although there are many pain medications to reduce the level of pain experienced by such patients, these drugs often are not sufficiently palliative and they typically can cause serious side effects.
One early invention to utilize magnetic fields to treat pain is described by Robert R, Holcomb in International Publication Number: WO 91/15263. The invention described in that document consists of four magnetic coils that are placed in the back of a chair or under a table where the patient's back would be exposed to the magnetic field. A DC current is placed through the four coils which results in an unchanging magnetic field to be experienced by the patient.
In U.S. Pat. No. 6,402,678, Robert E. Fischell, et al describe a device to be placed on the head which can eliminate or reduce the pain of migraine headaches by the application of a series of intense magnetic pulses. This device was approved by the US FDA on May 22, 2014 and is currently in use to treat patients with migraine headaches. The Fischell, et al migraine treatment device operates by charging capacitors to a high voltage and then discharging them into a magnetic coil to create a magnetic pulse as high as 0.8 Tesla in intensity. By Faraday's law, this changing magnetic pulse creates an electrical pulse within the skull that has been shown to eliminate migraine headaches. Because it takes about 45 seconds to charge the condensers from a battery within this Transcranial Magnetic Stimulation (TMS) device, the rate of applying magnetic pulses to the brain is extremely slow; i.e., typically about one pulse in about one minute. Even at that, the time rate of change of the magnetic field within the brain results in an electrical current in some neurons which eliminates most migraine headaches. However, the application of more pulses per unit time and at a higher magnetic field intensity with specially shaped magnetic coils could result in a more effective treatment for the relief of pain from other parts of the human body such as the feet for patients who suffer from diabetic neuropathy or cancer chemotherapy.
An existing system that is currently available to treat lower back pain is called TENS which is an acronym for Transcutaneous Electrical Nerve Stimulator. This device has two adhesive covered electrodes that are pasted onto the skin along the lower back. The device can then be turned on and adjusted so that the pain in the skin is acceptable while some electrical pulses enter the body in the vicinity of the spine where they can provide some relief for lower back pain. However, it would be highly advantageous to use a system that could provide higher intensity electrical pulses much deeper into the body without causing any skin pain. That can be accomplished with TransCutaneous Magnetic Stimulation or TCMS as described herein.
There is one issued patent and three patent applications by Donald Burnett et al namely U.S. Pat. No. 6,701,185 (the '185 patent), and the patent publications US2003/0158585 (the '585 publication), US2004/0210254 (the '254 publication) and US2012/0302821 (the '821 publication). The inventions described in the Burnett et al patent and publications all have a consistent design for the use of magnetic pulsations for the treatment of pain, namely, comparatively small wire coils with all wires being in circular form and placed against the skin of the foot or wrapped around the knee or elbow with the use of comparatively low electrical currents. Specifically, this prior art has the following numbers of generally circular or curved magnetic coils: the '185 reference 6 coils; the '585 reference, 10 coils; the '254 reference, 9 coils; and the '821 reference, 30 coils. Not even one of these 49 coil designs has even one straight wire section for placement anywhere on a human body. The Burnett et al references describe 23 different coil designs placed against the side of the foot and three different designs that are needles placed against the side of the foot. At no point in any of these prior art documents is there any design surrounding the foot and no Burnett et al design even closely approximates a shoe-shaped coil that is placed around the foot which is undoubtedly the optimum configuration for the application of magnetic pulsations to treat foot pain.